510(k) Report

510(k) · Cleared

Cleared

Humid-Vent Filter Pedi

K952084510(k) TraditionalCleared Jun 12, 199540-day reviewClass I21 CFR 868.5375

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Gibeck, Inc. · BYD Condenser, Heat And Moisture (Artificial Nose)

Cleared on Jun 12, 1995 after a 40-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 12, 1995
Review
40 days
Class
Class I
Product code
BYD
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2024: 1 descendant cleared2022: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952084 Humid-Vent Filter PediGibeck, Inc. · 1995
  2. Descendant · cites it directly · 2 of its ownK163300 ThermoShield HME FilterFlexicare Medical Limited. · 2017
  3. Descendant · 2 generations on · 0 of its ownK241339 Besmed Bacterial Filter and HMEFBesmed Health Business Corp · 2024
  4. Descendant · 2 generations on · 0 of its ownK210352 GGM Breathing Circuit Bacterial FilterGreat Group Medical Co, Ltd. · 2022

Most influential descendants

Showing 3 of 3 · See all
  • K163300ThermoShield HME FilterFlexicare Medical Limited. · 2017 · cites it directly2descendants
  • K241339Besmed Bacterial Filter and HMEFBesmed Health Business Corp · 2024 · 2 generations on0descendants
  • K210352GGM Breathing Circuit Bacterial FilterGreat Group Medical Co, Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952084Humid-Vent Filter PediGibeck, Inc.1995—
+1K163300ThermoShield HME FilterFlexicare Medical Limited.2017—
+2K241339Besmed Bacterial Filter and HMEFBesmed Health Business Corp2024—
+2K210352GGM Breathing Circuit Bacterial FilterGreat Group Medical Co, Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
202210
202410
FIG. 1 — Lineage of K952084, 1995–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in BYD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K163300ThermoShield HME FilterFlexicare Medical Limited.20172

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K163300 (Flexicare Medical Limited., 2017) has gone furthest, with 2 descendants of its own.

How does its category compare?

All BYD devices

BYD Condenser, Heat And Moisture (Artificial Nose): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BYD

FDA has decided no BYD device since 2007.

Median 510(k) review, days · BYD

Too few BYD 510(k)s in any year since 2007 to give a median.

Recalls per year · BYD

3in 2024

2011: 12014: 1, 1 Class I2015: 1, 1 Class I2020: 12024: 3
2007high 3 (2024) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · BYD

52in 2025

2007: 42008: 22009: 22010: 92011: 72012: 42013: 42014: 62015: 172016: 182017: 122018: 332019: 152020: 352021: 152022: 322023: 452024: 102025: 52
2007high 52 (2025) · low 2 (2008)2025

MAUDE reports naming product code BYD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—04
20080—02
20090—02
20100—09
20110—17
20120—04
20130—04
20140—1 (1)6
20150—1 (1)17
20160—018
20170—012
20180—033
20190—015
20200—135
20210—015
20220—032
20230—045
20240—310
20250—052
20260—0—

More from Gibeck, Inc.

15 FDA decisions under this applicant name. See the company

  • K965016Iso-Gard Filter Angled (18212)/Iso-Gard Filter Straight (19212)Gibeck, Inc. · 19976 Class I recalls
  • K964377Thermal Regulation System BlanketGibeck, Inc. · 1997
  • K964382Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402)Gibeck, Inc. · 1997
  • K960511Gibeck Warmbag Reusable Convective Warming BlanketGibeck, Inc. · 1997
  • K954828Iso-Gard Hepa Filter-Hme, Iso-Ard Hepa Filter-Hme W/PortGibeck, Inc. · 1996

Recent decisions in BYD

The BYD category page

  • K955008Heat & Moisture ExchangerIntertech Resources, Inc. · 1996
  • K954194Disposable Hme/FilterEngstrom Medical · 1995
  • K953580Heat Moisture ExchangerIntertech Resources, Inc. · 1995
  • K953507Type 1 & 2 (Humidair I & II)Icor AB · 1995
  • K953540EEEEdentec Corp. · 1995

https://510kreport.com/device/K952084 · printed Nov 5, 2026

Cite this page

510(k) Report. “K952084: Humid-Vent Filter Pedi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952084

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026